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QA supervisor
Job responsibilities:
1. Responsible for organizing the formulation of the
company's quality management system and the audit of relevant GMP documents,
and preparing the audit work.
2. Organize and implement the quality control of R&D
and pilot process.
3. Responsible for the IQ/OQ and daily calibration of the
core process equipment;
4. Organize and implement the inspection work on the
retention samples and stability of QC's main materials and products;
5. Arrange deviation, change control and other
investigation and audit according to the regulations, and propose and track the
implementation of CAPA.
6. Assist the quality director in the implementation of GMP
training, and coordinated the work relationship between the department and
other departments;
7. Participate in supplier quality audit and product
quality review.
QA specialist
Job responsibilities:
1. Responsible for the management of quality files, and
responsible for the management of GMP files;
2. Supervise and check the original records (including
relevant records of equipment and equipment), batch records, reports and
retention samples, and verify the integrity and authenticity of the data;
3. Organize and coordinate the preparation, revision and
audit of GMP documents; Responsible for the release and implementation of GMP
documents;
4. Conduct inspection and inspection on the implementation
of GMP in all departments, and conduct follow-up and analysis on quality
issues;
5. Assist the purchasing department in the material supplier assessment, and established the list of qualified suppliers and the supplier files;
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